Penicillin for the Emergency Department Outpatient Treatment of CELLulitis (PEDOCELL)
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|ClinicalTrials.gov Identifier: NCT02922686|
Recruitment Status : Not yet recruiting
First Posted : October 4, 2016
Last Update Posted : October 4, 2016
The main objective of this study is to investigate the non-inferiority of oral flucloxacillin alone compared with a combination of oral flucloxacillin and phenoxymethylpenicillin for the emergency department directed outpatient treatment of cellulitis, wound infections and abscesses, recently renamed by the Food and Drug Administration (FDA) as acute bacterial skin and skin structure infections (ABSSSIs). Half of the trial participants will receive flucloxacillin and placebo in combination, and the remaining half will be treated will flucloxacillin and phenoxymethylpenicillin.
In a secondary objective the trial aims to measure adherence and persistence of trial patients with outpatient antibiotic therapy. In addition a within-trial evaluation of the cost per quality adjusted life year (QALY) gained from the use of oral flucloxacillin compared with combination therapy from the perspective of the health-care payer (direct costs) the patient and government. Finally the study will externally validate the Extremity Soft Tissue Infection-score, a Health Related Quality of Life (HRQL) questionnaire designed to quantify the impact of cellulitis, wound infections and abscesses on patient HRQL in clinical trials.
|Condition or disease||Intervention/treatment||Phase|
|Cellulitis Wound Infection Abscess||Drug: Flucloxacillin Drug: Phenoxymethylpenicillin Drug: Placebo (for phenoxymethylpenicillin)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||414 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Oral Flucloxacillin Alone Versus Flucloxacillin and Phenoxymethylpenicillin for the Emergency Department Outpatient Treatment of Cellulitis: a Non-inferiority Randomised Controlled Trial.|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Active Comparator: flucloxacillin + phenoxymethylpenicillin
Flucloxacillin 500 mg four times daily + Phenoxymethylpenicillin 500 mg four times daily for 7 days.
One flucloxacillin capsule of 500mg strength taken four times daily for 7 days
One capsule of phenoxymethylpenicillin of 500 mg strength taken four times daily for 7 days
Other Name: Marketing Authorisation Number PL; 04520/0005
Placebo Comparator: flucloxacillin + placebo
Flucloxacillin 500 mg four times daily + Placebo four times daily for 7 days.
One flucloxacillin capsule of 500mg strength taken four times daily for 7 days
Drug: Placebo (for phenoxymethylpenicillin)
Over-encapsulation of phenoxymethylpenicillin will be performed by the manufacturer of the investigational medicinal products such that placebo and active phenoxymethylpenicillin are identical in size, shape, colour and smell, and are packaged in identical bottles
Other Name: Over-encapsulated investigative medicinal product.
- Investigator-determined clinical response [ Time Frame: Test Of Cure visit (Day 14-21 post randomization) ]A trained member of the study team will determine clinical cure at the test of cure visit. This is a clinically-determined response to treatment based on the judgment of the trained member of the study team. Clinical cure will be defined as no treatment failure at any previous visit, and resolution or minimal presence of the erythema, swelling, tenderness, or induration from the baseline assessment, based on the study investigators clinical assessment
- Early Clinical Response (ECR) [ Time Frame: Day 2-3 post randomization ]Early clinical response is defined as greater than or equal to a 20% reduction in the lesion surface area from that which was measured at enrolment.
- Clinical Treatment Failure [ Time Frame: Up to 21 days post randomization ]Any patient outcome designated as a clinical treatment failure at any time before and including the test of cure visit, will be categorized as a treatment failure. This commences with the early clinical response visit and includes serial changes in the surface area of the cellulitis lesion (erythema, oedema, tenderness and induration), clinical assessment of progress and health related quality of life measurements.
- Adherence to Medication [ Time Frame: End of Treatment (EOT) visit Day 8-10 post randomization ]Medication adherence will be measured by counting the number of unused study medication at the end of treatment visit
- Adherence to medication using an electronic medication event monitoring system (MEMS®) [ Time Frame: Day 2-3 and day 8-10 post randomization and initiation of therapy ]A specific sub-study will be performed measuring adherence and persistence to antibiotic treatment using a MEMS® cap. The cap will be fitted to the dispensed medication bottle. MEMS® caps will be returned with the clinical trials supplies on the follow up visits.medication at the end of treatment visit
- Measurement of Health Related Quality of Life [ Time Frame: Day 2-3 post-randomization, Day 8-10 post randomization, Day 14 -21 post randomization ]The EuroQol (EQ-5D-5L) will be used to obtain patient reports of health related quality of life and used in the estimation of quality adjusted life years.
- Validation of the Extremity Soft Tissue Infections (ESTI)- score [ Time Frame: Day 2-3 post-randomization, Day 8-10 post randomization, Day 14 -21 post randomization ]The ESTI will be used to obtain patient reports of health related quality of life and will be mapped on to EQ-5D-5L levels, to assess the accuracy of ESTI for use in cost-effectiveness studies
- Cost-effectiveness analysis [ Time Frame: Day 14 - 21 post randomization ]Analysis will consist of a within-trial evaluation of the cost QALY for oral flucloxacillin compared with oral flucloxacillin and phenoxymethylpenicillin over a one month time horizon from the perspective of the healthcare payer, the patient and the government. The CE analysis will use resource use data, where costs will be assigned to derive cost and will also use the QALY derived from the EQ5D-5L, to give overall cost per QALY.
- Measurement of Health Resource Use [ Time Frame: Day 2-3 post-randomization, Day 8-10 post randomization, Day 14 -21 post randomization ]A health economics resource utilization tool is being constructed to collect data on resource use, e.g. direct costs- hospital visits, primary care visits, and indirect costs such as transport and lost work productivity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922686
|Contact: Abel Wakai, MD FRCEM||003531 firstname.lastname@example.org|
|Contact: Michael Quirke, MB FRCEM||00353 1 email@example.com|
|Department of Emergency Medicine, Connolly Hospital,||Not yet recruiting|
|Blanchardstown, Dublin, Ireland, Dublin 15|
|Contact: Joseph McKeever firstname.lastname@example.org|
|Department of Emergency Medicine, Mercy University Cork||Not yet recruiting|
|Cork, Greenville Place, Ireland, Cork|
|Contact: Chris Luke|
|Department of Emergency Medicine, Cork University Hospital||Not yet recruiting|
|Cork, Wilton, Ireland, Cork|
|Contact: Conor Deasy email@example.com|
|Department of Emergency Medicine, Mater Misericordiae University Hospital||Not yet recruiting|
|Dublin, Ireland, Dublin 7|
|Contact: Adrian Moughty firstname.lastname@example.org|
|Contact: Michael Quirke|
|Beaumont Hospital,||Not yet recruiting|
|Dublin, Ireland, Dublin 9|
|Contact: Abel Wakai, MD FRCEM email@example.com|
|Contact: Michael Quirke firstname.lastname@example.org|
|Principal Investigator: Abel Wakai, MD FRCEM|
|Principal Investigator:||Adrian Moughty||Mater Misericordiae University Hospital|
|Principal Investigator:||Joseph McKeever||Connolly Hospital Blanchardstown|
|Principal Investigator:||Conor Deasy||Department of Emergency Medicine, Cork University Hopsital, Cork|
|Principal Investigator:||Chris Luke||Department of Emergency Medicine, Mercy University, Cork|
|Principal Investigator:||Abel Wakai, MD FRCEM||Department of Emergency Medicine, Beaumont Hospital, Dublin|